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Compliance Services

Clinical Research Compliance Office

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Our Mission

The Clinical Research Compliance Office (CRCO) was created in an effort to consolidate and initiate university-wide quality assurance (QA) of human subjects research, strategic initiatives in the area of human subjects research, and internal assessment and compliance with applicable regulations governing human subjects research.

Our website/services:

  • About CRCO: Our background, roles and responsibilities, and current initiatives.
  • Audits: CRCO manages Indiana University‚Äôs auditing program for human subjects research.
  • Investigational New Drug Application (IND) and Investigational Device Exemption (IDE): CRCO partners with the Indiana Clinical and Translational Sciences Institute (CTSI) to provides education and tools to help Indiana University investigators who are conducting research with drugs, biological products or devices regulated by the Food and Drug Administration (FDA). This includes education and support for investigators who hold an IND or IDE.
  • IU Health System-wide IRB: CRCO develops and implements a system-wide IRB with IU Health. See our process and our resources for this partnership.
  • Education: CRCO offers training and education on clinical research.
  • Anonymous Reporting Hotline: CRCO facilitates resolutions of complaints or concerns received via an anonymous hotline
  • Research Misconduct: CRCO supports the Research Integrity Officer with allegations in research misconduct
  • Contact CRCO
  • Research Billing Compliance: CRCO oversees the Clinical Research Billing Compliance program